| Function: | Urinary System Agents |
|---|---|
| Certification: | GMP, FDA |
| Grade Standard: | Medicine Grade |
| Type: | Chemical Reagent |
| State: | Solid |
| Volatile: | Not Volatile |
| Samples: |
|---|
| Customization: |
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Name: Spironolactones
CAS No.: 52-01-7
Formula: C24H32O4S
Molecular Weight: 416.62
Density: 1.24 g/cm3
Melting Point: 207-208 °C(lit.)
Boiling Point: 597 °C at 760 mmHg
Flash Point: 302.3 °C
Solubility: practically insoluble in water
Appearance: White to Off White Solid
Used as a diuretic, lactone (spironolactones), the active metabolite. Inhibition of aldosterone biosynthesis. Wow effect of blockers for Pakistan It is a synthetic 17-lactone steroid which is a renal competitive aldosterone antagonist in a class of pharmaceuticals called potassium-sparing diuretics, used primarily to treat ascites in patients with liver disease, low-renin hypertension, hypokalemia.
Description
Aldactone removes excess fluid from the body in congestive heart failure, cirrhosis of the liver, and kidney disease.
It also can be used in combination with other drugs to treat elevated blood pressure, and for treating diuretic-induced low potassium (hypokalemia).
Aldactone also is used to counteract the effects of excessive adrenal aldosterone production (hyperaldosteronism). Aldosterone overproduction can occur from a tumor in the adrenal gland or enlarged adrenal glands (hyperplasia of the adrenal glands).
Spironolactones Specification:
| Ref. standard | EP8/USP39 | |
| Analysis items | Specification | Results |
| Appearance | white or yellowish-white powder | White powder |
| Solubility | Practically insoluble in water, soluble in ethanol(96 per cent). | Complies |
| Identification | A/B/C Meet the requirements | Complies |
| Specific rotation |
- 41 to -46°(EP) / -41 to -45°(USP) |
-43° |
| Loss on drying | Not more than 0.5% | 0.08% |
| Sulfated ash | Not more than 0.1% | 0.03% |
|
Impurity A and Impurity C |
Not more than 0.2% |
N.D |
|
Impurity F and Impurity E |
Not more than 0.3% | N.D |
| Impurity D | Not more than 0.15% | N.D |
| Impurity I | Not more than 0.5% | N.D |
| Other arbitrary unknown impurities | Not more than 0.1% | Complies |
| Total impurities | Not more than 0.7% | 0.15% |
| Ordinary impurities(USP) | Not more than 2.0% | 0.05% |
| Free thiol compounds(EP) | Not more than 0.05 ml | Complies |
| Free mercapto compounds(USP) | Not more than 0.1ml | Complies |
| Chromium(EP) | 50ppmNot more than 50ppm | Complies |
| Assay |
97.0%~103.0%(USP) / 97.5-102%(EP) |
99.9% (USP) / 100.1% (EP) |
| Fineness | 95% Not more than 20 μm | Complies |
| Conclusion | Qualified | |
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